Process Development Engineer II

JOB SUMMARY
As a member of the companies Sequencing Unit's Manufacturing Sciences and Technology (MSAT) team, the Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. This contractor role bridges new product implementation and process optimization to maintain high product quality, improve yields, and enhance manufacturing robustness. The role operates within a matrix organization, collaborating with cross-functional and multinational teams to ensure compliance, process capability, and product supply integrity.

Responsibilities
Technical Support:
• Provide hands-on support to troubleshoot manufacturing processes and drive improvement initiatives.
• Conduct product and process characterization, including capability studies and identification of critical parameters.
• Author and maintain Work Instructions and other production-related documentation in compliance with quality standards.
• Design and implement In-Process Controls (IPCs) to monitor CTQs during manufacturing.
• Develop and maintain CTQ-Scorecards to track performance against quality attributes.
• Lead or support root cause investigations using structured methodologies (e.g., Kepner-Tregoe, 5 Whys, Fishbone Analysis).
• Partner with cross-functional teams for specification development, process characterization, and material qualification.
• Plan and execute Design of Experiments (DOE) and perform statistical analysis using tools such as JMP or Minitab.

Continuous and Process Improvement:
• Lead strategic improvement initiatives targeting cost reduction, yield improvement, and process efficiency.
• Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., pFMEA).
• Collaborate across the companies network to share and implement best practices.
• Quality Mindset:
• Ensure compliance with Quality System requirements through document control, change management, and monitoring.
• Participate in and support audits, CAPAs, NCRs, and validation of methods and systems.
• Other duties as assigned by management.

QUALIFICATIONS
Formal Training/Education
• Bachelors degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Equivalent combinations of education and/or experience are acceptable.

Experience
• Minimum 5 years in medical device, IVD, or regulated manufacturing roles.
• Experience working in a GMP or ISO 13485 compliant manufacturing environment, with direct involvement in process validation (IQ/OQ/PQ) and technology transfer from R&D to Operations
• Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production preferred.
• Hands-on experience in several of the following areas is highly desirable:
• Biosensor or semiconductor manufacturing, especially processes involving functionalized surfaces.
• Automated liquid handling, reagent dispensing, and precision fluidics.
• Working in a cleanroom environment.?
• Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).
• Prior experience authoring and managing production documentation in ERP systems (e.g., SAP).

Knowledge, Skills and Abilities
• Strong communication, collaboration, and influencing skills across all levels.
• Ability to independently manage technical tasks and projects with minimal supervision.
• Demonstrated experience implementing in-process controls and CTQ metrics.
• Demonstrated ability with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis.
• Familiarity with Lean and Six Sigma principles (Green Belt certification preferred).
• Working knowledge of FDA Quality System Regulation (QSR) 21 CFR 820 and ISO 13485 standards.

Licenses and Certifications (OPTIONAL)
• LEAN/Six Sigma Certification - Green Belt preferred (attainable within 12 months).

Travel Requirements
Estimated Amount: 10%
Brief Description: Domestic and international travel based on business needs.

Pay ranges between $55-70/hr based on experience